Controlled Cord Traction During Third Stage of Labor

Summary

Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were
caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries.
Where maternal mortality is high and resources are limited, the introduction of low-cost,
evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord
traction (CCT) is actively promoted in combination with prophylactic uterotonics for the
prevention of PPH. While the administration of uterotonics has been proven effective, there
is no evidence of CCT being beneficial or safe. The investigators propose this study to
evaluate two primary questions:

1. In women having term, single vaginal deliveries in hospital settings, in whom the third
stage is managed with prophylactic oxytocin, does CCT produce a clinically significant
reduction in the incidence of postpartum blood lose?

2. In these women, does CCT produce a clinically significant increase in the incidence of
severe complications, including uterine inversion or the need for subsequent surgical
evacuation of retained placental tissues and membranes (curettage or manual removal)?

To answer these two questions we designed two arms randomized controlled trial.

Description

Subjects This study will be conducted in two Public Hospital from Montevideo, Uruguay. A
total of 200 women (100 by group) will be recruited.

Description of the Study Design This will be a two-arm, randomized controlled clinical trial
in which 200 women having a single vaginal delivery and receiving prophylactic oxytocin for
the management of the third stage of labor at two public hospital in Montevideo will be
allocated to one of two interventions: CCT or a "hands-off" policy. All outcomes will be
measured before maternal discharge from the hospital. The primary outcome is postpartum
blood loss.

Duration of the Study We estimate that we will need a total of 11 months to complete this
study. Three months will be needed for preparation (installing data collection resources and
training data collectors and birth attendants), and 6 months for recruitment, and two months
for data analysis and preparation of reports and manuscripts.

Where Subjects Are/ Study Site and Populations The study will be conducted in two public
hospitals from Montevideo, Uruguay. These are third level public hospitals supported by the
University of the Republic, with a total of 9,900 deliveries per year.

Full Description of Risks There is no evidence to suggest that there were risks from this
study to the women or the newborns, because it is not known if CCT is associated with
serious complications in the mother. In all previous active management trials and in the two
CCT trials, there were no reported cases of uterine inversion, and currently, CCT is the
recommended standard of care during delivery. In theory, the most severe potential
complication is uterine inversion, which can be a life-threatening condition if adequate
care is not provided. However, this event is unlikely with the simultaneous use of
uterotonics to assure a well contracted uterus and eventually, it can be successfully
managed in hospital settings.

Benefits for Subjects and/or Society:

We do not expect a clinical and important benefit from this study at an individual level of
the pregnant women. However, this study will provide useful information to evaluate one
specific intervention recommended for the management of third stage of labor.

Inducement for Participants:

No monetary inducement will be offered to the participants.

Costs to Subjects: N/A

Statistical Analysis Before addressing the research question, descriptive statistics and
summary graphics such as histograms will be prepared and examined for outcomes and
demographic variables. All analyses addressing the study research questions will use the
"intention to treat" principle, thus comparing the original intervention group to the
original nonintervention group, even if individuals have withdrawn from the study or shifted
to another group. The analysis plan and presentation of results will follow the
recommendation of the CONSORT statement. In this study the primary outcome is continues
(blood loss), therefore, median and inter-quartile ranges will be computed as part of
descriptive data analysis to understand the distribution of the outcome variables and to
assess the need of data transformation or adoption of nonparametric tests, including
Mann-Whitney U tests. Means for the two groups will be compared by the two-sample t-test. A
similar analysis will be performed for the duration (in minutes) of the third stage of
labor.

Methods of Recruitment:

Enrollment will be done during and previous to women's labor at the maternity. Screening
will start at the time of admission and when possible during prenatal care, and for those
eligible women, a signed consent form will be required. Sealed envelopes opened just before
delivery(at delivery guard) will be used to determine whether the woman should receive CCT
or not. A random allocation scheme will be derived from a computer-generated list of
numbers, with randomly permuted blocks.

Informed Consent Services directors will provide written authorization to participate in
this study. Individual birth attendants will receive an information sheet describing the
objectives of the study and including the name and phone number of the study coordinator.
Birth attendants will also be invited to participate in the training workshops. Women will
be invited to participate upon admission to the hospital (or during prenatal care when
possible) and, if they agree to participate, will provide written informed consent to their
birth attendant. The birth attendant will then be required to disclose to the patient all
of the facts about the nature of the trial, interventions under comparison, the risks
involved, available alternatives and their risk, and reasonable expectations for the
treatment outcome. This study was submitted to the Institutional Review Board of the School
of Medicine, University of Uruguay for approval and the Institutional Review Board of Tulane
University . The PI and co-PI have attended training sessions on the protection of human
subjects and have been certified by the Institutional Review Boards at their institutions.
The coordinator and research assistant invited to participate in this study will be asked to
complete an on-line training session on protection of human subjects.

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Medical and Biotech [MESH] Definitions

Traction

The pull on a limb or a part thereof. Skin traction (indirect traction) is applied by using a bandage to pull on the skin and fascia where light traction is required. Skeletal traction (direct traction), however, uses pins or wires inserted through bone and is attached to weights, pulleys, and ropes. (From Blauvelt & Nelson, A Manual of Orthopaedic Terminology, 5th ed)

Extraoral Traction Appliances

Extraoral devices for applying force to the dentition in order to avoid some of the problems in anchorage control met with in intermaxillary traction and to apply force in directions not otherwise possible.

Vacuum Extraction, Obstetrical

Removal of the fetus from the uterus or vagina at or near the end of pregnancy with a metal traction cup that is attached to the fetus' head. Negative pressure is applied and traction is made on a chain passed through the suction tube. (From Stedman, 26th ed & Dorland, 28th ed)

Spinal Cord Vascular Diseases

Pathological processes involving any of the BLOOD VESSELS feeding the SPINAL CORD, such as the anterior and paired posterior spinal arteries or their many branches. Disease processes may include ATHEROSCLEROSIS; EMBOLISM; and ARTERIOVENOUS MALFORMATIONS leading to ISCHEMIA or HEMORRHAGE into the spinal cord (hematomyelia).

Central Cord Syndrome

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

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